ETHICON OMNEX SURGICAL SEALANT

FDA Premarket Approval P060029

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

Approval for the ethicon omnex surgical sealant. The device is indicated for use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.

DeviceETHICON OMNEX SURGICAL SEALANT
Generic NameSealant, Polymerizing
ApplicantETHICON, INC.
Date Received2006-10-26
Decision Date2010-06-03
Notice Date2010-06-11
PMAP060029
SupplementS
Product CodeNBE 
Docket Number10M-0285
Advisory CommitteeCardiovascular
Expedited ReviewNo
Combination Product No
Applicant Address ETHICON, INC. route 22 West somerville, NJ 08876
Summary:Summary of Safety and Effectiveness
Labeling: Labeling
Approval Order: Approval Order

Supplemental Filings

Supplement NumberDateSupplement Type
P060029Original Filing
S005 2013-01-08 Normal 180 Day Track
S004 2012-05-29 30-day Notice
S003 2011-06-29 Normal 180 Day Track No User Fee
S002
S001 2010-07-09 Real-time Process

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